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Recall Observatory FDA recall evidence

Drug product

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

D-0809-2016

December 17, 2015

Class III

Product summary

Firm
Bio-pharm, Inc.
Event
Event 72819
Status
Terminated
Classification
Class III
Quantity
103,664 Bottles
Official record key
drug-enforcement:D-0809-2016

Official wording

Reason: Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Code information: Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications